BioMimetic Therapeutics, Inc.
Biotech Specialty Pharma  Advamed Member
389-A Nichol Mill Lane
Franklin, TN 37067 USA
phone: 615-844-1280
fax: 615-844-1281
Symbol BMTI
Exchange NASDAQ
Founded 1999
Employees 85
www.biomimetics.com
Research Sector Biotech Specialty Pharma
Summary Description
Drug-Device Combination Products to treat Musculoskeletal Injury
Management
Samuel E. Lynch, D.M.D., D.M.Sc.- President & CEO Steven N. Hirsch- COO Larry Bullock- CFO Charles E. Hart, Ph.D- CSO Earl Douglas, General Counsel
Ownership
Financials Mkt Cap :214


* numbers in thousands

 
Keywords
Orthopedics, spine, ortho joint, reconstruction, ortho joint, reconstruction, advamed, bone fractures

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Description
BioMimetic Therapeutics, Inc. develops bio-active drug-device combination products to speed the healing of musculoskeletal injuries and diseases in periodontal, orthopedic, craniofacial, spine and sports injury indications. The company's products combine recombinant protein therapeutics with tissue specific scaffolds to actively stimulate tissue healing and regeneration.
Products / Services
BioMimetic's GEM 21S is an FDA approved product used to treat bone loss experienced in periodontal disease. The Augment Bone Graft (formerly GEM OS1 Bone Graft) is designed to stimulate bone regeneration; its targeted uses are in open fracture reduction and for fractures requiring surgery (foot and ankle fusion). Augment Injectable Bone Graft (formerly GEM OS2 Bone Graft) is an injectable product for bone augmentation and for the treatment of non-surgical fracture injuries. Cartilage, ligament and tendon product candidates (Augment C and Augment LT) using proprietary technology are also being developed to stimulate cartilage, ligament, and tendon repair and regeneration.
Technology / Differentiation
BioMimetic's GEM and Augment products utilize the FDA-approved recombinant human platelet derived growth factor (rhPDGF-BB) in combination with scaffolding materials that have a history of demonstrated safety and efficacy. rhPDGF attract cells necessary for tissue healing through chemotaxis, while also stimulating an increase in the number of healing cells through mitogenesis; these processes expand the number of cells available for the repair process. In addition, published in vivo and in vitro studies demonstrate that rhPDGF may enhance processes important in new blood vessel formation at the wound site, a process critical for wound healing. Consequently, rhPDGF-BB has been shown to enhance bone fracture repair and to strengthen the skeleton throughout the body.
Market / Customers
BioMimetic generated $33.4 million in cash from the January 2008 sale of its orofacial therapeutic business (including the downstream formulation, fill and finish manufacturing rights of GEM 21S) to Luitpold, who currently markets the product. The company will also receive $43.4 million in cash as a result of the transaction, plus ongoing royalty payments based on net sales of GEM 21S and future products in the dental and cranio-maxillofacial fields. The company's other product candidates represent many applications and high-value markets, and are expected to make a significant contribution to them upon FDA approval and marketing.
Status
BioMimetic submitted the Device License Application (DLA) for Augment Bone Graft to Health Canada in the second quarter of 2008, required for commercialization and for use in treatment of foot and ankle fusions. As of August 8, 2008, 200 patients have been enrolled in a U.S. pivotal trial (as well as 95 patients in a similar EU Clinical Study) evaluating the safety and effectiveness of Augment Bone Graft.


2008-11-23-1770